Evaluation of the Risk Management System for Medicinal Products in Kenya

Abstract

Background: All medicinal products have some inherent risks associated with them. Risk management of medicines focuses more on reduction of risks such as Adverse Drug Reactions (ADRs) and Medication Errors (MEs) rather than increasing the benefits. Hence an effective risk management system of medicines tries to ensure that the benefits outweigh the risks in order to protect the patient and target population. The International Conference on Harmonization (ICH) has developed a guideline known as the ICH E2E guideline on pharmacovigilance planning that has been used by developed countries in their risk management approach for medicinal products. Objective: The main objective of this study was to evaluate the risk management system for medicinal products in Kenya as carried out by the Pharmacy and Poisons Board (PPB) and selected multinational innovator pharmaceutical companies. A comparison was also made between established systems in the European Union (EU), United States of America (USA) and Kenya. Methodology: The study was divided into two phases. The first phase was a qualitative study aimed at eliciting information on the current risk management practices as carried out by the PPB and by selected multinational innovator pharmaceutical companies. This was achieved by conducting key informant interviews with regulatory affairs and pharmacovigilance experts. An assessment of the pharmacovigilance activities at PPB using the Indicator-based pharmacovigilance Assessment Tool (IPAT) was also done. The second phase was a crosssectional quantitative study of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) submitted by Marketing Authorization Holders (MAHs) to the PPB. For instance, data was collected on number and component of PSURs and RMPs and whether they conformed to ICH guidelines. Documentation on regulatory actions taken by PPB and MAHs in 2015 such as recalls of drugs, voluntary withdrawal of products and safety communications were also reviewed. Descriptive data analysis was carried out using Stata® version 13(Stata Corp, USA) with findings being presented as percentages, proportions, graphs and tables. Results: Ten (10) RMPs and two hundred and forty eight (248) PSURs were submitted between January and December 2015 to PPB. The RMPs were submitted by 2 innovator pharmaceutical companies, while the PSURs were submitted by 13 innovator pharmaceutical companies and 3 generic companies. The relatively few numbers of MAHs who submitted these documents as xx well as the low numbers of RMPs and PSURs submitted in 2015 could be attributed to lack of legislation requiring submission of PSURs and RMPs. 47.3% of the PSURs had either an active RMP, Risk Evaluation and Mitigation Strategies (REMS) or both during the reporting period, but none of them had been submitted in 2015. Out of the 9 RMPs that were submitted, 8(88.9%) did not have a corresponding PSUR yet the two go hand in hand in evaluating the benefit-risk profile of a medicinal product. Conclusion: Kenya has an inadequate risk management system for managing risks associated with medicinal products due to lack of an Act of Parliament enforcing submission of RMPs and PSURs. Unlike the EU and USA whereby there is a legal basis for the submission of PSURs and RMPs, Kenya lacks the relevant policies and regulations, accounting for the low reporting rate. There was also lack of legislation requiring MAHs to conduct postmarketing studies. There were no proper timelines for review and giving feedback to MAHs on the safety documents they submitted. Recommendations: Kenya has a draft Qualified Person for Pharmacovigilance (QPPV) guideline, that if enforced would see MAHs have a QPPV who would be tasked with the overall pharmacovigilance of medicines having marketing authorization, including timely submission of drug safety reports such as RMPs and being the contact person in case safety concerns were to arise with a product. Relevant pharmacovigilance legislation is crucial in strengthening pharmacovigilance, and revision of the Pharmacy and Poisons Act is needed to incorporate the pharmacovigilance legislation. This would among other things, give PPB the power to make it mandatory for pharmaceutical companies to submit RMPs especially for high risk medicines such as thalidomide, for which the same is required by stringent MRAs.